Regulatory Affairs Manager Job

Employer Name: PharmaceuticalCrossing	SpiderID: 2447034
Location: Princeton, New Jersey	Date Posted: 8/22/2008
Wage:	Category: Medical/Health
Job Code: 7532723

Job Description:
The position will interact with relevant departments to ensure regulatory requirements for these submissions are met and to communicate with Regulatory Authorities in order to expedite approval of submissions. To do this, the individual will be responsible for the accuracy, scientific validity and presentation of CMC documents in submissions and that they meet current best practice standards. This individual will be expected to effectively plan CMC submissions and work to agreed timelines and to identify regulatory CMC issues and resolve them as appropriate. Signature: ~CB~ Qualifications This position is open to internal and external candidates. A Bachelors Degree in a Science discipline with a minimum of 5 years experience in the Pharmaceutical industry at least 3 years of which are in regulatory affairs and or Chemistry & Manufactory Controls (CMC) function. Must be legally authorized to work in the United States Must be willing to work in our Princeton, NJ facility (or appropriate location) Must be willing to submit to a drug test and background check Must submit application for employment through gecareers.com to be considered Must be willing to travel at least 20% of the time (based on the need of the position) Desired Sound knowledge of regulatory CMC requirements and knowledge of general regulatory requirements Demonstrate a high ability to analyze CMC data and to identify and resolve regulatory issues. Ability to communicate well verbally and in writing as this position will be expected to communicate findings both verbally and in written reports. Demonstrate good interpersonal skills required to build relationships with and influence internal departments and externally with Regulatory Authorities.

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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:

Contact Information:

Contact Name: -	Company Type: Employer
Company: PharmaceuticalCrossing

City: Pasadena
State: California
Zip:

Web Site: http://www.pharmaceuticalcrossing.com